FDA.report

ORLocate

Primary DI
50724995220155
Brand
ORLocate
Company
Steris Corporation
Model
ORLocate Vaginal Packing
Catalog number
VAG4X36LPFLNS
Device description
ORLocate RFID Vaginal Packing Loop and Fold is used with the ORLocate Sponge Solution System.
Published
2023-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GDYGauze/sponge, internal, x-ray detectable

Product Code Classifications

CodeDeviceSpecialtyClass
GDYGauze/Sponge, Internal, X-Ray DetectableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50724995220155PackageGS12In Commercial Distribution
15060356150158PreviousGS10
10724995220157PrimaryGS10
00724995220150Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5072499522015550724995220155
1506035615015815060356150158
1072499522015710724995220157
00724995220150007249952201507249952201500724995220150

GMDN Terms

TermDefinition
Radiopaque woven surgical spongeA non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.

Device Sizes

TypeValueUnit
Length36Inch
Width4Inch

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags

DUNS number
177360039
Device count
240
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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